Regulatory Specialist Ii
Current• Process Continuing Review Reports, Study Modifications, Closures, Miscellaneous Items, and Repository Study Modification submissions for Expedited Review through electronic review systems to Institutional Review Board (IRB) for institution with over 400 active studies • Maintain approval documentation for external IRBs (e.g. WCG IRB, Advarra, etc.) and upload approved informed consent documents to the Clinical Research Study Management system • Process all new studies, significant and minor changes, closures, and administrative items for the Institutional Animal Care and Use Committee (IACUC) utilizing the electronic review system for full committee meetings and Designated Member Review, and working with the IACUC Chair and Attending Veterinarian for administrative items including preparing agenda and minutes for monthly meetings in support of Principal Investigators at the institute